SUMMARY

The global regulation of food supplements involves diverse requirements and market authorization processes, shaped by the distinct regulations of individual countries or regions. This encompasses diverse aspects, including ingredient and formulation standards, where different nations maintain specific lists of permitted and prohibited components, requiring compliance with established safety criteria. Good Manufacturing Practices (GMP) are often mandated to ensure product quality, safety, and consistency. Accurate labeling, supported by scientific evidence for health claims plays a crucial role, demanding clear and accurate information on ingredients, dosage, and usage instructions, with health claims necessitating scientific support and adherence to regulatory guidelines. Notification or approval procedures vary, with some countries mandating pre-market registration. Safety assessments, encompassing toxicity and risk analysis, are obligatory to ensure consumer well-being. Packaging and storage requirements are defined to maintain product integrity. Regulatory authorities, such as the FDA, EFSA, and TGA, oversee market authorization in respective countries. Post-market surveillance, including mandatory adverse event reporting, is common. International efforts aim for harmonization, exemplified by organizations like Codex Alimentarius, emphasizing the importance for manufacturers and distributors to comprehend and adhere to specific market regulations to ensure the legal and safe distribution of food supplements. Many products combine the characteristics of medical devices, medicinal products, food supplements, cosmetics and biocides to form the so-called borderline product group. Inappropriate qualification of a product may result in a decision by the supervisory authorities to suspend/withdraw it from the market.